Ebglyss (lebrikizumab-lbkz) / Roche, Almirall, Eli Lilly - LARVOL DELTA

P109 Lebrikizumab for the treatment of moderate-to-severe atopic eczema: real-world experience from a tertiary centre. (PubMed, Br J Dermatol) - "Ten patients experienced ocular symptoms while on dupilumab (n = 8) or tralokinumab (n = 3). Moreover, lebrikizumab serves as a viable alternative for patients who experienced ocular complications with previous biologic therapies. Further long-term follow-up is essential in larger cohorts to fully assess the future role of lebrikizumab."

Journal • Real-world evidence • Retrospective data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13

P113 JAK in the box: unlocking real-world factors influencing Janus kinase inhibitor and dupilumab prescribing in atopic dermatitis. (PubMed, Br J Dermatol) - "A retrospective review was carried out of patients aged ≥ 12 years prescribed dupilumab or a JAKi (upadacitinib, abrocitinib or baricitinib) for AD in our tertiary dermatology centre between 2021 and 2024. Tralokinumab and lebrikizumab were excluded as all patients had prior dupilumab...Factors favouring dupilumab prescribing include older age, asthma status and cardiovascular risk factors. Factors favouring JAKi prescribing included speed of onset, ease of prescribing, younger age and needle phobia."

Journal • Real-world evidence • Retrospective data • Alopecia • Asthma • Atopic Dermatitis • Cardiovascular • Dermatitis • Dermatology • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hypertension • Immunology • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Pulmonary Disease • Respiratory Diseases • Thrombosis • STAT2

P102 Raising the bar of efficacy in atopic dermatitis: lebrikizumab provides deep clinical and itch responses up to 16 weeks (ADvantage study). (PubMed, Br J Dermatol) - P3 | "Around 17% of patients had been previously exposed to dupilumab. Lilly has exclusive rights for the development and commercialization of lebrikizumab in the USA and the rest of the world outside of Europe. Medical writing was funded by Almirall S.A."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13

BI35 A case of dupilumab-induced scalp psoriasis and review of the literature. (PubMed, Br J Dermatol) - "The AD was ineffectively controlled by topical steroids, ultraviolet therapy and abrocitinib. He was trialled on methotrexate (up to 12.5 mg per week), which helped control his eczema but was discontinued because of deranged liver function. He continued to develop severe recurrent flare-ups requiring treatment with short-term oral prednisolone and then ciclosporin...His AD is being managed with lebrikizumab...Hypothetically, the blockade of the T helper (Th)2 response with dupilumab by targeting the IL-4/IL-13 signalling pathway could result in a shift towards a Th1/Th17 phenotype, leading to an inflammatory cytokine cascade and eventually psoriatic skin plaques, as described in this report. Dermatologists should be aware of psoriasis as a potential adverse event with dupilumab."

Journal • Review • Allergic Rhinitis • Alopecia • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Mood Disorders • Psoriasis • Psychiatry • Pulmonary Disease • Respiratory Diseases • IL13 • IL4

P104 Lebrikizumab improves quality of life in patients with moderate-to-severe atopic dermatitis inadequately controlled or ineligible for ciclosporin (ADvantage study). (PubMed, Br J Dermatol) - P3 | "Lilly has exclusive rights for the development and commercialization of lebrikizumab in the USA and the rest of the world outside of Europe. Medical writing was funded by Almirall S.A."

Clinical • HEOR • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

P105 Lebrikizumab improves quality of life and wellbeing of patients with moderate-to-severe atopic dermatitis inadequately controlled with or ineligible for ciclosporin: German extension results (week 76) of the ADvantage study. (PubMed, Br J Dermatol) - P3 | "Lilly has exclusive rights for the development and commercialization of lebrikizumab in the USA and the rest of the world outside of Europe. Medical writing was funded by Almirall S.A."

Clinical • HEOR • Journal • Atopic Dermatitis • Breast Cancer • Dermatitis • Dermatology • Diabetes • Immunology • Metabolic Disorders • Oncology • Solid Tumor • IL13

Preclinical development of an anti-IL-13 antibody for the treatment of atopic dermatitis (ISDS 2025) - "Type 2 inflammatory pathway antagonism is safe and effective in the treatment of atopic dermatitis, with multiple approved drugs targeting the cytokine IL-13 (Ebglyss, Adbry) or its receptor IL-4R (Dupixent), and other IL-13 antagonists showing success in clinical development with half-life extended molecules (APG777). These molecules demonstrate pM IL-13 affinity, efficient antagonism of IL-13 signaling in both reporter cell lines and primary keratinocytes, extended half-life properties, and manufacturability and stability profiles consistent with commercially validated therapeutics. These candidates open the door to synergistic combinations pairing IL-13 antagonism with complementary pathway inhibition, for the treatment of inflammatory diseases like atopic dermatitis, particularly addressing patients whose disease remains inadequately controlled by existing systemic therapies."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4R

Impact of type 2-targeted therapies on respiratory infection risk. (PubMed, Curr Opin Allergy Clin Immunol) - "T2-modulating biologics not only control allergic inflammation but also restore epithelial and immune homeostasis, contributing to maintained or reduced respiratory infection risk. These therapies represent a dual benefit of barrier repair and immune rebalancing. Further studies are warranted to evaluate long-term infection outcomes in high-risk populations."

Journal • Allergy • Infectious Disease • Inflammation • Respiratory Diseases • IL13 • IL4 • IL5

Lebrikizumab for the Treatment of Moderate to Severe Atopic Eczema: Real-World Experience from a Tertiary Centre. (PubMed, Dermatol Ther (Heidelb)) - "In this real-world cohort of patients with atopic dermatitis, lebrikizumab demonstrated efficacy comparable to that observed in clinical trials. It may provide an alternative treatment option for individuals who have discontinued other biologics as a result of conjunctivitis."

Journal • Real-world evidence • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13

Atopic Dermatitis Successfully Treated with Lebrikizumab in Real-World Clinical Practice in Czech Republic: A Case Series. (PubMed, Dermatol Ther (Heidelb)) - "All four patients had failed previous targeted therapies (biologics or Janus kinase inhibitors) and/or cyclosporine treatments and presented with associated comorbidities. After 12 to 16 weeks of treatment with lebrikizumab, clinically significant improvements in signs and symptoms (assessed by Eczema Area and Severity Index [EASI], pruritus Numerical Rate Scale, quality of life assessed by the Dermatology Life Quality Index [DLQI], and/or Patient Oriented Eczema Measure [POEM]) were reported. The results of these four clinical cases support the effectiveness observed in randomized clinical trials and suggest that lebrikizumab may be an effective treatment for moderate-severe AD in real-world clinical practice, even in patients with comorbidities who have failed previous advanced treatments."

Clinical • Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • IL13

Efficacy of Lebrikizumab on Pruritus: A Narrative Review. (PubMed, Adv Ther) - "Lebrikizumab has shown efficacy across diverse populations, including adolescents, the elderly, and skin of color. By effectively targeting IL-13, lebrikizumab offers a valuable treatment option for moderate-to-severe AD, providing significant and sustained pruritus relief, skin clearance, and quality of life improvements."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13

Efficacy and Safety Evaluation of Different Lebrikizumab Dosages in Atopic Dermatitis Patients Over 16 to 24 Weeks: A BIOREP Registry Analysis. (PubMed, Int J Dermatol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Real-World Effectiveness and Safety of Lebrikizumab in Moderate-to-Severe Atopic Dermatitis: A Multicenter Study From Spain. (PubMed, Int J Dermatol) - No abstract available

Clinical • Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Dual Therapy for Atopic Dermatitis: How Lebrikizumab and JAK inhibitors are used in Tandem for Treatment Resistant Cases (ISDS 2025) - "Five patients discontinued dual therapy: three transitioned to an alternative combination regimen (Cibinqo/Abry, Rinvoq/Dupixent, Cibinqo/Ebglyss) and two reverted to monotherapy due to AD control and simplifying regimen or to minimize side effects. AD management requires individualized approaches, particularly in patients who do not respond to conventional therapies. Combinations, such as Lebrikizumab plus a JAK inhibitor, may expand treatment options for refractory cases. In this cohort, dual therapy demonstrated encouraging efficacy and acceptable tolerability, highlighting the need for larger studies to further define its role in AD management."

Clinical • Acne Vulgaris • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • IL13 • IL4

Lebrikizumab Dosed Every 8 Weeks as Maintenance Provides Long-Lasting Response in Patients with Moderate-to-Severe Atopic Dermatitis (ISDS 2025) - "Lebrikizumab, every 8 or 4 weeks, provided long-lasting response in moderate-to-severe AD, supporting its durable and potential disease-modifying effect."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

PRAC updated SmPC sections 4.8 and 5.1 for lebrikizumab to include new efficacy and long-term safety data from the 100-week ADjoin (J2T-DM-KGAA) study in moderate to severe atopic dermatitis. RMP version 1.1 was submitted, and the MAH implemented PEI linguistic and editorial updates to the Product Information. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 29 Sep - 2 Oct 2025: PRAC adopted an update to SmPC section 5.1 for lebrikizumab to include new clinical efficacy data from the J2T-AP-KGBQ (Advantage) phase 3 study, a randomized, double-blind, placebo-controlled trial evaluating lebrikizumab with topical corticosteroids for up to 52 weeks in patients with moderate to severe atopic dermatitis inadequately controlled with or ineligible for ciclosporin. [AI generated summary]

PRAC • Atopic Dermatitis • Immunology

Cost-Effectiveness Analysis of Lebrikizumab vs. Alternative Biologics in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis in the UK (ISPOR-EU 2025) - "Biologics (lebrikizumab, dupilumab, tralokinumab) and JAK inhibitors are recommended by NICE and the Scottish Medicines Consortium for treating moderate-to-severe AD in patients that are not suitable for or have not responded to at least one systemic immunosuppressant. Commercial arrangements add further value to real world incremental costs and lebrikizumab is considered cost-effective against alternative biologics and was recommended for reimbursement by UK HTA agencies in AD patients that are not suitable for or have not responded to at least one systemic immunosuppressant. Lebrikizumab generates more QALYs than comparator biologics."

Clinical • Cost effectiveness • HEOR • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Almirall continues its sustained growth trajectory in 9M 2025 - delivering 12.8% net sales growth, strong dermatology performance, solid commercial execution in Europe, and further pipeline progress (PharmiWeb) - "Ebglyss, for the treatment of moderate to severe atopic dermatitis, generated €75.5 MM of sales during 9M 2025 – representing more than a 3x increase YoY, as European markets are ramping up after launch...Ilumetri, for the treatment of psoriasis, grew steadily in 9M 2025, with net sales increasing 12% YoY, to a total of €170.9 MM and remaining on track to meet the €300 MM peak sales target....Almirall’s broad dermatology product portfolio continues to show strong performance, further enhancing the company´s relevance to patients and dermatologists. In 9M 2025 Wynzora grew 32.3% YoY to a total of €25.4 MM, and Klisyri grew 22.6% YoY to a total of €20.1 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Psoriasis

Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis. (PubMed, Clin Exp Dermatol) - P3 | "A majority of lebrikizumab Week 16 responders maintained stable efficacy in measures of skin and itch during 2 years of treatment."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13

Letter: Lebrikizumab for Refractory Atopic Dermatitis. (PubMed, Dermatitis) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Systemic Hypereosinophilia and Severe Erythroderma Triggered by Dupilumab in a Case of Adult-Onset Dermatitis (ACAAI 2025) - "Cyclosporine followed by lebrikizumab were given without benefit. The combination of late-onset dermatitis, marked eosinophilia, and intractable pruritus signals the necessity for systemic evaluation and multidisciplinary collaboration. Ruling out malignancy, infection, or hypersensitivity is crucial for effective treatment and symptom relief."

Clinical • Asthma • Atopic Dermatitis • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Dermatopathology • Diabetes • Eosinophilia • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Metabolic Disorders • Pruritus • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Type 2 Diabetes Mellitus • CD4 • IL13 • IL4

Lebrikizumab Effectively Treats Moderate-to-Severe Atopic Dermatitis in Adolescent Patients with Atopic Comorbidities (ACAAI 2025) - P3 | "CDLQI, PROMIS-A, PROMIS-D mean improvements from BL were similar regardless of atopic comorbidity status at W16 and W52. Conclusions LEB treatment resulted in clinically meaningful improvements in adolescent patients with moderate-to-severe AD, regardless of coexisting atopic comorbidities at W16 and W52."

Clinical • Allergic Rhinitis • Asthma • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Mood Disorders • Psychiatry • Respiratory Diseases

Efficacy of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis With Comorbid Allergic Rhinitis (ACAAI 2025) - "Response rates for the PBO (LEBRI withdrawal), LEBRI250Q4W, and LEBRI250Q2W groups, respectively, were: EASI 75 (63.2%, 87.9%, 78.3%), EASI 90 (46.0%, 80.0%, 69.1%), IGA 0/1 (41.9%, 81.4%, 65.6%), and PNRS4 (75.7%, 87.6%, 82.4%). Conclusion Induction and maintenance response rates in patients with AR aligned with overall population rates, supporting LEBRI’s long-term efficacy in moderate-to-severe AD, irrespective of AR comorbidity."

Clinical • Allergic Rhinitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13

Lebrikizumab Improves Disease Control And Work Activity In Atopic Dermatitis Patients With Skin Of Color (ACAAI 2025) - "The activity impairment score (all patients) also improved (44.5%, SD=33.0% vs 19.1%, SD=24.2%). Conclusion Lebrikizumab increased patient-reported disease control and workplace productivity in patients with moderate-to-severe AD and skin of color."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Product Theater 1 (non-CME) - Lilly : Explore EBGLYSS®(lebrikizumab-lbkz): See How EBGLYSS Can Leave a Lasting Impression (ACAAI 2025) - "This program features early and long-term data, safety, dosing information, and how to get patients started on EBGLYSS. Also visit Lilly at Booth #1519 ."